Effect of Atorvastatin on Bone-vascular Axis

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

Background: Circulating osteoprogenitors and RANKL expression in immune cells have been implicated in the pathogenesis of osteoporosis and vascular calcification. The role played by statin therapy in the bone-vascular axis is unknown.

Methods: Twenty naïve post-menopausal osteoporotic hypercholesterolemic women will be treated with Atorvastatin 40 mg/day for three months. Blood samples will be collected at baseline and at the end of the treatment. Gene expression analysis will be performed to assess modification in OPG/RANK/RANKL expression in isolated T-cells and monocytes. A flow cytometry analysis will be used to study changes in the levels of circulating osteoprogenitor cells.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Newly diagnosed osteoporosis (T score ≤ -2.5 SD at either the lumbar spine or femoral neck)

• LDL-cholesterol ≥ 130 mg/dl

Exclusion Criteria:

• History of bone fractures,

• Clinical evidence of atherosclerotic disease

• CKD (stage III-V),

• Liver disease

• COPD

• Rheumatic disorders;

• Current or previous treatment with statins, steroids, hormonal replacement therapies, and antiosteoporotic drugs (including vitamin D and calcium supplementation)